DRUG DESCRIPTION

METROCREAM® Topical Cream contains metronidazole, USP, at a concentration
of 7.5 mg per gram (0.75%) in an emollient cream consisting of benzyl alcohol,
emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution,
lactic acid and/or sodium hydroxide to adjust pH. Metronidazole is a member
of the imidazole class of antibacterial agents and is classified therapeutically
as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol.
The molecular formula is C6H9N3O3
and molecular weight is 171.16. Metronidazole is represented by the following
structural formula:

What are the possible side effects of metronidazole topical (MetroCream, MetroGel, MetroLotion, Noritate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have severe stinging or burning when you apply metronidazole topical.

Less serious side effects may include:

mild burning or stinging when the medication is applied;

numbness or tingly feeling in your hands or feet;

cough, stuffy nose, sore throat, cold symptoms;

...

Read All Potential Side Effects and See Pictures of MetroCream »

What are the precautions when taking metronidazole topical cream (MetroCream)?

Before using metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazole antibiotics (such as tinidazole); or to other ingredients in this product; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Discuss the risks and benefits with your doctor before...

Read All Potential Precautions of MetroCream »

MetroCream Consumer (continued)

SIDE EFFECTS: Stinging, burning, skin irritation, dryness, redness, metallic taste, nausea, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you have this unlikely but serious side effect: tingling or numbness of the hands and feet.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazole antibiotics (such as tinidazole); or to other ingredients in this product; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

MetroCream Patient Information Including Side Effects

Brand Names: MetroCream, MetroGel, MetroLotion, Noritate

What are the possible side effects of metronidazole topical (MetroCream)?

What is the most important information I should know about metronidazole topical (MetroCream)?

What should I discuss with my doctor before using metronidazole topical (MetroCream)?

How should I use metronidazole topical (MetroCream)?

What happens if I miss a dose (MetroCream)?

What happens if I overdose (MetroCream)?

What should I avoid while using metronidazole topical (MetroCream)?

What other drugs will affect metronidazole topical (MetroCream)?

Where can I get more information?

What is metronidazole topical (MetroCream)?

Metronidazole is an antibiotic that fights bacteria in the body.

Metronidazole topical (for the skin) is used to treat skin lesions caused by rosacea.

Metronidazole topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of metronidazole topical (MetroCream)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have severe stinging or burning when you apply metronidazole topical.

Less serious side effects may include:

mild burning or stinging when the medication is applied;

numbness or tingly feeling in your hands or feet;

cough, stuffy nose, sore throat, cold symptoms;

vaginal itching or discharge;

headache;

dry, scaly, or itchy skin;

nausea; or

metallic taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about metronidazole topical (MetroCream)?

Do not use metronidazole topical if you have ever had an allergic reaction to it.

Before using metronidazole topical, tell your doctor if you are allergic to any drugs, or if you have a blood cell disorder such as anemia or decreased white blood cells.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin).

Metronidazole topical is for use only on the skin. Avoid getting this medication in your eyes. If this does happen, rinse thoroughly with cool water. Do not use topical metronidazole in the vagina.

Call your doctor if you have severe stinging or burning when you apply metronidazole topical.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before any infection is completely treated. Do not use metronidazole topical to treat any other skin infection your doctor has not prescribed it for.